MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON CLAREON PANOPTIX TORIC TRIFOCAL UV ABSORBING IOL; LENS, INTRAOCULAR, TORIC OPTICS

Model Number	CCWTT4
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Impairment (2138); Visual Disturbances (2140)
Date of Event	08/20/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A non health care professional reported that following an intraocular lens (iol) implant procedure, the patient experienced blurred vision, glare, halos and light sensitivity.The iol was explanted and exchanged with an unknown atiol (advanced technology intraocular lens) in the secondary implant procedure.Procedure completed on the subsequent day.Additional information was received stating that the clinical reason for the explant was mechanical complication defect of iol (right eye) causing diminished vision and glare.Patient cannot tolerate residual astigmatism (toric overcorrection).The iol was explanted and exchanged with non company lens.Surgeons prognosis states patient vision was clear.
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Additional information has been provided in h.3., h.6., and h.11.The lens was returned adhered in dried viscoelastic to a small white piece of paper sealed inside a blue, non-company pouch.The lens was cleaned with klrp (klotho-related protein) to release from the paper and to further evaluate.No damage was observed to the lens.A retest of the power (spherical and cylinder) and optical resolution was conducted by an engineering technician.The lens met specifications for a company lens with 20.0 diopter.Product history records were reviewed and documentation indicated the product met release criteria.Qualified associated products were indicated.The root cause cannot be determined for the reported vision complaint.Each lens is subjected to a 100 percent assessment of the power (spherical and cylinder) and optical resolution during the manufacturing process in order to determine acceptability per the lens model and diopter.The returned lens was cleaned to remove the dried viscoelastic and conduct testing.The power and resolution were retested.The lens met specifications for a company lens with 20.0 diopter.No damage was observed to the lens.The multifocal toric company lens (2.25 cylindrical 20.0 diopter (add power +2.2/+3.2 diopter) lens was removed and replaced with a non-company non-toric monofocal lens model (20.5 diopter).Due to a multifocal toric being replaced with a monofocal non-toric lens suggests that a monofocal non-toric lens was an improved selection for this patient's vision needs.The manufacturer internal reference number is: (b)(4).

• Brand Name: CLAREON PANOPTIX TORIC TRIFOCAL UV ABSORBING IOL
• Common Device Name: LENS, INTRAOCULAR, TORIC OPTICS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 246 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 246 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 22521088
• Report Number: 1119421-2025-01948
• Device Sequence Number: 18130538
• Product Code: MJP
• UDI-Device Identifier: 00380652457910
• UDI-Public: (01)00380652457910(17)260208(11)220210(10)15351952
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/08/2026
• Device Model Number: CCWTT4
• Device Catalogue Number: CCWTT4.200
• Device Lot Number: 15351952
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/23/2025
• Supplement Date Received by Manufacturer: 08/04/2025
• Initial Report FDA Received Date: 07/16/2025
• Supplement Report FDA Received Date: 08/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/10/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DUOVISC VISCOELASTIC SYSTEM.; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D.; MONARCH III IOL DELIVERY SYSTEM, INJECTOR.; UNSPECIFIED FORCEPS.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male